CLASS II Device recall · Reported 17 Dec 2014 · FDA Enforcement Report
Soft Contact Lens recalled by Cooper Vision Caribbean
Cooper Vision Caribbean is recalling Soft Contact Lens, distributed nationwide in the US. The recall was initiated on 28 Oct 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0529-2015
- FDA event ID
- 69496
- Recalling firm
- Cooper Vision Caribbean, Juana Diaz, PR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Oct 2014
- FDA classified
- 9 Dec 2014
- Reported
- 17 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Contact Lenses & Eye Devices
Timeline
| 28 Oct 2014 | Recall initiated by company | |
| 9 Dec 2014 | Classified by FDA | +42 days |
| 17 Dec 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Portions of the lots may contain units with an incorrect lens axis condition.
Product as listed by the FDA
Soft Contact Lens
Where it was distributed
US Nationwide Distribution.
Questions about this recall
Is Soft Contact Lens recalled?
Yes. Cooper Vision Caribbean recalled Soft Contact Lens on 28 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0529-2015.
Why was it recalled?
Portions of the lots may contain units with an incorrect lens axis condition.
Which lots are affected?
Lots # 8246525202 & 8255525096
Where was it sold?
US Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Mold | Nationwide |
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